The purpose of this study is comparing therapeutic effects of two common anti epileptic drugs; phenytoin and depakin; in aborting serial seizures.
Our inclusion criteria are age older than 18 years old and at least two tonic- clonic generalized seizures (with complete recovery of consciousness between them) during last 24 hours. Exclusion criteria including status epilepticus, pregnancy and presence of any contraindication for administration phenytoin or depakin such as heart block, hepatic failure and ....
Sample size will be sixty patients that will be divided in two groups according to random chart. One group receiving intravenous phenytoin 18mg/kg and other group receiving intravenous depakin 20mg/kg stat that will continue with maintenance dose at 1mg/kg/hour for 24 hours. All patients will be under close observation for 24 hours after administration of drugs. Drug efficacy defined as complete cease of seizures that will be evaluate during 24 hours after administration of drugs.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013012012208N1
Registration date:2013-04-28, 1392/02/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-04-28, 1392/02/08
Registrant information
Name
Mohammed Reza Raeyat
Name of organization / entity
Department of Neurology, Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1230 1607
Email address
raeyatr@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellery of Research and Technology, Shiraz University of Medical Sciences
Expected recruitment start date
2013-02-03, 1391/11/15
Expected recruitment end date
2013-03-05, 1391/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison efficacy of depakin and phenytoin in aborting serial seizures.
Public title
comparison of depakin and phenytoin in serial seizures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-age>18y/o 2- SS is defined as 2 generalized tonic clonic seizures in 1 hour or more than 2 generalized tonic clonic seizures in 24 hours. Patients should regain full level of consciousness between attacks.
Exclusion criteria: 1-Status epilepticus 2-Pregnancy 3-Hepatic failure 4-renal failure 5-Younger than 18 years old phenytoin such as heart disease, drug sensivity, systolic blood pressure less than 100mmhg, heart rate less than 60/min
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University Of Medical Sciences
Street address
Shiraz University Of Medical Sciences, Zand Boulevard, Shiraz
City
Shiraz
Postal code
7134814336
Approval date
2012-07-12, 1391/04/22
Ethics committee reference number
ct-91-1950
Health conditions studied
1
Description of health condition studied
Epilepsy
ICD-10 code
G40.3
ICD-10 code description
Generalized idiopathic epilepsy and epileptic syndromes
Primary outcomes
1
Description
number of seizures during 24 hours after treatment
Timepoint
24 hours
Method of measurement
observe patient and completing a form
Secondary outcomes
1
Description
cardiac rhythm
Timepoint
continuous monitoring
Method of measurement
Heart minitoring device
2
Description
Blood pressure
Timepoint
continuous monitornig
Method of measurement
Digital blood pressure manitor
3
Description
Haert Rate
Timepoint
Continuous Monitoring
Method of measurement
Haert monitoring device
Intervention groups
1
Description
Administration Depakin (Na valproate) IV at dose 20mg/kg stat then 1mg/kg/hour for 24 hours
Category
Treatment - Drugs
2
Description
Administration Phenytoin (IV) at dose 18 mg/kg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Namazi Hospital
Full name of responsible person
Raeyat Mohammed Reza
Street address
Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Vice-Chancellery of Research and Technology
Street address
Shiraz University Of Medical Sciences, Zand Boulevard, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Neurology, Shiraz University Of Medical Sciences
Full name of responsible person
Raeyat Mohammed Reza
Position
Resident of Neurology
Other areas of specialty/work
Street address
Department of Neurology, Shiraz University Of Medical Sciences, Zand Boulevard, Shiraz
City
Shiraz
Postal code
7134814336
Phone
+98 71 1612 1065
Fax
Email
raeyatr@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Neurology, Shiraz University Of Medical Sciences
Full name of responsible person
Petramfar Petram
Position
MD
Other areas of specialty/work
Street address
Department of Neurology, Shiraz University Of Medical Sciences, Zand Boulevard, Shiraz
City
Shiraz
Postal code
7134814336
Phone
+98 71 1612 1065
Fax
Email
petramfar@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Neurology, Shiraz University Of Medical Sciences
Full name of responsible person
Raeyat Mohammed Reza
Position
Resident of Neurology
Other areas of specialty/work
Street address
Department of Neurology, Shiraz University Of Medical Sciences, Zand Boulevard, Shiraz
City
Shiraz
Postal code
7134814336
Phone
+98 71 1612 1065
Fax
Email
raeyatr@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)